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Claims for Patent: 9,248,123

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Claims for Patent: 9,248,123

Title:Methods of providing weight loss therapy in patients with major depression
Abstract: Disclosed are methods of providing weight loss therapy, particularly for patients suffering from major depression.
Inventor(s): Dunayevich; Eduardo (San Diego, CA), Tollefson; Gary (Indianapolis, IN)
Assignee: Orexigen Therapeutics, Inc. (La Jolla, CA)
Application Number:12/987,909
Patent Claims: 1. A method for providing weight loss therapy to a patient, comprising: identifying an overweight or obese patient who is suffering from major depressive disorder; and reducing weight of the patient by administering to the patient a pharmaceutical weight loss therapy comprising naltrexone or a pharmaceutically acceptable salt thereof and bupropion or a pharmaceutically acceptable salt thereof, wherein the amount of naltrexone or pharmaceutically acceptable salt thereof is about 32 mg per day and the amount of the bupropion or pharmaceutically acceptable salt thereof is about 360 mg per day, and wherein said method provides about the same amount of weight loss in overweight or obese patients who are suffering from major depressive disorder as in overweight or obese patients who are not suffering from major depressive disorder.

2. The method of claim 1, further comprising reducing symptoms of depression in the patient.

3. The method of claim 1, wherein the patient is overweight.

4. The method of claim 1, wherein the patient is obese.

5. The method of claim 1, wherein the naltrexone or a pharmaceutically acceptable salt thereof and bupropion or a pharmaceutically acceptable salt thereof is administered once per day.

6. The method of claim 1, wherein the naltrexone or a pharmaceutically acceptable salt thereof and bupropion or a pharmaceutically acceptable salt thereof is administered more than once per day.

7. The method of claim 1, wherein the naltrexone or pharmaceutically acceptable salt thereof is administered prior to or subsequent to the bupropion or pharmaceutically acceptable salt thereof.

8. The method of claim 1, wherein the naltrexone or pharmaceutically acceptable salt thereof and the bupropion or pharmaceutically acceptable salt thereof are in a single oral dosage form.

9. The method of claim 8, wherein the single oral dosage form further comprises a pharmaceutically acceptable excipient, diluent, or carrier.

10. The method of claim 1, wherein the daily dose of the naltrexone or pharmaceutically acceptable salt thereof is escalated from 8 mg in week one to 16 mg in week two, 24 mg in week three, and 32 mg in week four and thereafter; and wherein the daily dose of the bupropion or pharmaceutically acceptable salt thereof is escalated from 90 mg in week one to 180 mg in week two, 270 mg in week three, and 360 mg in week four and thereafter.

11. The method of claim 10, wherein at least one of the naltrexone or pharmaceutically acceptable salt thereof and bupropion or pharmaceutically acceptable salt thereof is in a sustained release formulation.

12. The method of claim 11, wherein the naltrexone or pharmaceutically acceptable salt thereof and the bupropion or pharmaceutically acceptable salt thereof are in a single oral dosage form.

13. The method of claim 10, wherein each of the naltrexone or pharmaceutically acceptable salt thereof and bupropion or pharmaceutically acceptable salt thereof is in a sustained release formulation.

14. The method of claim 13, wherein the naltrexone or pharmaceutically acceptable salt thereof and the bupropion or pharmaceutically acceptable salt thereof are in a single oral dosage form.

15. The method of claim 1, wherein at least one of the naltrexone or pharmaceutically acceptable salt thereof and bupropion or pharmaceutically acceptable salt thereof is in a sustained release formulation.

16. The method of claim 1, wherein each of the naltrexone or pharmaceutically acceptable salt thereof and bupropion or pharmaceutically acceptable salt thereof is in a sustained release formulation.

17. The method of claim 1, wherein the pharmaceutical weight loss therapy consists essentially of naltrexone or a pharmaceutically acceptable salt thereof and bupropion or a pharmaceutically acceptable salt thereof.

18. The method of claim 1, wherein said method further reduces the symptoms of depression in the patient.
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